Corsier-sur-Vevey, Vaud, Switzerland
18 hours ago
Quality Assurance Lead Expert (all genders)

 

Work Your Magic with us!  

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


An exciting new opportunity has arisen to join us as Quality Assurance Lead Expert for our Biotech drug substance plant in Corsier sur Vevey.

 

Your role

 

As an integral member of the Quality Unit, you provide QA expertise for the computerized system validation/Automation and data integrity. The role consists to elaborate the CSV/Automation & DI strategies, leads risk analysis, identifies gap and purposes remediation plan. You act as Senior Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics as part of this new facility project. You review and/or approve qualification documents (equipment, software and hardware), risk assessment, SOPs and take quality decisions according to company standards. With digitalization lots of projects are to come.

The activities of the QA Senior Expert cover all qualification phases from Basic Design until 1st use of equipment/software. You ensure GMP compliance during all phases of qualification/validation.

You will be also in front line during health autorities inspection to present our strategies on CSV and in direct contact with the global team in charge of the elaboration of the company strategies regarding CSV to represent the site.

 

Who you are

 

University or relevant engineering degreeAt least 5 years’ experience in CSV in pharmaceutical industry or equivalentKnowledge in cGMP and health authority expectationsStrong Knowledge in Data Integrity is mandatory as well as risk managementExperience in Equipment (Utilities/E&M/Production/Lab equipment) qualification is a plusGood interpersonal skills, with a positive attitude and the ability to support his colleagues in a context of growth and changesExcellent written communication skillsFluent in French & English (written & spoken)

 


What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

 

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